Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligib… (NCT04531046) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation
Belgium, France62 participantsStarted 2021-03-10
Plain-language summary
This is a phase 2, open-label, multicenter study evaluating axicabtagene ciloleucel (axi-cel) as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient who understands and speaks one of the country official languages and signed Informed Consent Form
* Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), follicular lymphoma Grade 3B per World Health Organization (WHO) 2016 classification and Primary mediastinal Bcell lymphomas. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with Rituximab-Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP) are eligible.
* Tumoral tissue (at diagnosis or relapse) available for central pathology review, exploratory endpoints and ancillary studies
* Positron-emission tomography (PET)-positive disease
* Patients must have received adequate first-line therapy including at a minimum: an anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (CHOP) or CHOP-like chemotherapy
* Relapsed or refractory disease after first-line chemoimmunotherapy (full dose of R-CHOP or R-CHOP-like regimen), documented by PET-scan
* At least 2 weeks must have elapsed since any prior systemic cancer therapy at the time the patient provides consent
* Patients must be autologous stem cell transplantation (ASCT)-ineligible
* Patients must be CAR-T-eligible
* Females of childbearing potential must have a negative serum or urine…
What they're measuring
1
Complete Metabolic Response (CMR) - determined by investigator
Timeframe: 3 months from axi-cel infusion
Trial details
NCT IDNCT04531046
SponsorThe Lymphoma Academic Research Organisation